Weill Medical College of Cornell University, New York-Presbyterian Hospital/Weill Cornell Medical Center, NY, USA.
Eur Urol. 2013 Jan;63(1):158-65. doi: 10.1016/j.eururo.2012.07.003. Epub 2012 Jul 17.
Alpha blockers are prescribed to manage lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Antimuscarinics are prescribed to treat overactive bladder (OAB).
To investigate the safety of a combination of solifenacin (SOLI) and tamsulosin oral controlled absorption system (TOCAS) in men with LUTS and bladder outlet obstruction (BOO).
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, parallel-group, placebo-controlled study in men aged >45 yr with LUTS and BOO for ≥3 mo, total International Prostate Symptom Score (IPSS) ≥8, BOO index ≥20, maximum urinary flow rate (Q(max)) ≤12 ml/s, and voided volume ≥120 ml.
Once-daily coadministration of TOCAS 0.4 mg plus SOLI 6 mg, TOCAS 0.4 mg plus SOLI 9 mg, or placebo for 12 wk.
Primary (safety) measurements: Q(max) and detrusor pressure at Q(max) (P(det)Q(max)). Other safety assessments included postvoid residual (PVR) volume. Secondary end points included bladder contractile index (BCI) score and percent bladder voiding efficiency (BVE). An analysis of covariance model compared each TOCAS plus SOLI combination with placebo.
Both active treatment groups were noninferior to placebo at end of treatment (EOT) for P(det)Q(max) and Q(max). Mean change from baseline PVR was significantly higher at all time points for TOCAS 0.4 mg plus SOLI 6 mg, and at weeks 2, 12, and EOT for TOCAS 0.4 mg plus SOLI 9 mg versus placebo. Both treatment groups were similar to placebo for BCI and BVE. Urinary retention was seen in only one patient receiving TOCAS 0.4 mg plus SOLI 6 mg. Limitations of the study were that prostate size and prostate-specific antigen level were not measured.
TOCAS 0.4 mg plus SOLI 6 mg or 9 mg was noninferior to placebo at EOT for P(det)Q(max) and Q(max) in men with LUTS and BOO, and there was no clinical or statistical evidence of increased risk of urinary retention.
α受体阻滞剂被用于治疗与良性前列腺增生（BPH）相关的下尿路症状（LUTS）。抗胆碱能药物被用于治疗膀胱过度活动症（OAB）。
研究索利那新（SOLI）和坦索罗辛口服控释系统（TOCAS）联合治疗伴有逼尿肌出口梗阻（BOO）的 LUTS 男性的安全性。
设计、地点和参与者：这是一项多中心、随机、双盲、平行组、安慰剂对照研究，纳入年龄>45 岁、LUTS 伴 BOO 时间≥3 个月、总国际前列腺症状评分（IPSS）≥8、BOO 指数≥20、最大尿流率（Qmax）≤12ml/s 和排尿量≥120ml 的男性。
每日一次联合服用 TOCAS 0.4mg 加 SOLI 6mg、TOCAS 0.4mg 加 SOLI 9mg 或安慰剂治疗 12 周。
主要（安全性）观察测量指标：Qmax 和最大尿流率时逼尿肌压（PdetQmax）。其他安全性评估包括残余尿量（PVR）。次要终点包括膀胱收缩指数（BCI）评分和膀胱排空效率（BVE）的百分比。协方差模型分析比较了 TOCAS 联合 SOLI 各治疗组与安慰剂的差异。
治疗结束时（EOT），与安慰剂相比，两种活性治疗组在 PdetQmax 和 Qmax 方面均非劣效。TOCAS 0.4mg 加 SOLI 6mg 组在所有时间点的平均基线 PVR 变化均显著高于安慰剂组，TOCAS 0.4mg 加 SOLI 9mg 组在第 2、12 和 EOT 时也显著高于安慰剂组。与安慰剂相比，两组的 BCI 和 BVE 均相似。只有一名患者在接受 TOCAS 0.4mg 加 SOLI 6mg 治疗时出现尿潴留。研究的局限性在于未测量前列腺大小和前列腺特异性抗原水平。
TOCAS 0.4mg 加 SOLI 6mg 或 9mg 与安慰剂相比，EOT 时在 PdetQmax 和 Qmax 方面非劣效，且没有增加尿潴留风险的临床或统计学证据。
